[Federal Register Volume 59, Number 75 (Tuesday, April 19, 1994)] [Unknown Section] [Page 0] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-9350] [[Page Unknown]] [Federal Register: April 19, 1994] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. 94M-0063] Medtronic, Inc.; Premarket Approval of the MedtronicTransvene Lead System AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing its approval of the application by Medtronic, Inc., Minneapolis, MN, for premarket approval, under section 515 of the Federal Food, Drug, and Cosmetic Act (the act), of the Medtronic Transvene Lead System. After reviewing the recommendation of the Circulatory System Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of December 9, 1993, of the approval of the application. DATES: Petitions for administrative review by May 19, 1994. ADDRESSES: Written requests for copies of the summary of safety and effectiveness data and petitions for administrative review to the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Doris J. Terry, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 1390 Piccard Dr., Rockville, MD 20850, 301-594-1523. SUPPLEMENTARY INFORMATION: On April 1, 1992, Medtronic, Inc., Minneapolis, MN, 55432, submitted to CDRH an application for premarket approval of the Medtronic Transvene Lead System. The device is a transvenous defibrillation lead system and is intended for single long-term use, and each lead is designed to be used only with a compatible Medtronic, Inc., implantable tachyarrhythmia control device along with at least one other Medtronic, Inc., defibrillator lead. The lead system has application where implantable tachyarrhythmia cardioversion or defibrillation systems are indicated. Current medical research indicates that such patients should: (1) Have survived at least one episode of a cardiac arrest, presumably due to a ventricular tachyarrhythmia as evidenced by resuscitation using a transthoracic defibrillator. The ventricular tachyarrhythmia should not have been caused by an acute myocardial infarction; or (2) in the absence of a prior cardiac arrest, have poorly tolerated sustained ventricular tachycardia and/or ventricular fibrillation, which occurs spontaneously, or can be induced, despite the best antiarrhythmic drug therapy. The natural history of patients with hemodynamically stable sustained ventricular tachycardia is not well defined. While this patient population was included in the Transvene lead clinical study, no conclusions were drawn from the data obtained on this specific patient group. Prior to a Transvene implant, it is strongly recommended that patients undergo a complete cardiac evaluation, which should include extensive electrophysiologic testing. Also, extensive electrophysiologic evaluation and testing of the safety and efficacy of the proposed pacing, cardioversion, or defibrillation therapies are recommended during and after the implantation of the Transvene system. On August 2, 1993, the Circulatory System Devices Panel of the Medical Devices Advisory Committee, an FDA advisory committee, reviewed and recommended approval of the application. On December 9, 1993, CDRH approved the application by a letter to the applicant from the Acting Director of the Office of Device Evaluation, CDRH. A summary of the safety and effectiveness data on which CDRH based its approval is on file in the Dockets Management Branch (address above) and is available from that office upon written request. Requests should be identified with the name of the device and the docket number found in brackets in the heading of this document. Opportunity for Administrative Review Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any interested person to petition, under section 515(g) of the act (21 U.S.C. 360e(g)), for administrative review of CDRH's decision to approve this application. A petitioner may request either a formal hearing under part 12 (21 CFR part 12) of FDA's administrative practices and procedures regulations or a review of the application and CDRH's action by an independent advisory committee of experts. A petition is to be in the form of a petition for reconsideration under Sec. 10.33(b) (21 CFR 10.33(b)). A petitioner shall identify the form of review requested (hearing or independent advisory committee) and shall submit with the petition supporting data and information showing that there is a genuine and substantial issue of material fact for resolution through administrative review. After reviewing the petition, FDA will decide whether to grant or deny the petition and will publish a notice of its decision in the Federal Register. If FDA grants the petition, the notice will state the issue to be reviewed, the form of review to be used, the persons who may participate in the review, the time and place where the review will occur, and other details. Petitioners may, at any time on or before May 19, 1994, file with the Dockets Management Branch (address above) two copies of each petition and supporting data and information, identified with the name of the device and the docket number found in brackets in the heading of this document. Received petitions may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. This notice is issued under the Federal Food, Drug, and Cosmetic Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) and redelegated to the Center for Devices and Radiological Health (21 CFR 5.53). Dated: April 5, 1994. Joseph A. Levitt, Deputy Director for Regulations Policy, Center for Devices and Radiological Health. [FR Doc. 94-9350 Filed 4-18-94; 8:45 am] BILLING CODE 4160-01-F